An Observational Study on Respiratory Complications After Gastrointestinal Endoscopy Assisted With Anesthesia

Completed

• Conditions: Pneumonia, Aspiration

• Registration Number: NCT06705894
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.

Detailed Description

Gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.With the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.The painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.However, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.

Study Timeline

• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Study First Posted: 2024-11-26
• Study Start: 2024-12-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6739

Inclusion Criteria

1. Age ≥18 years old;
2. Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;

Exclusion Criteria

1. Patients with respiratory system symptoms or history before surgery;
2. Patients in need of a tracheal intubation;
3. Refuse follow-up;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative cough	24 hours after surgery	The investigator needs to use NRS scores to evaluate the severity of the cough, if patients develop a new cough after surgery.The score from 0 (no) to 10 (extremely serious).Duration and treatment are also required to be recorded.
Postoperative fever	24 hours after surgery	The investigator needs to record the patient's maximum body temperature. Duration and treatment are also required to be recorded.
Short of breath	24 hours after surgery	The investigator needs to use mMRC questionnaire to evaluate the severity of SOB.Duration and treatment are also required to be recorded.

Secondary Outcome Measures

Name	Time	Method
Adverse events during surgery	During surgery	Adverse events such as coughing, reflux aspiration, laryngeal spasm, and hypotension need to be recorded.

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shangdong, China